Quality criteria for randomized controlled studies: obstetrical journal guidelines

Abstract

Background:

Most retractions of ob-gyn manuscripts are due to scientific misconduct. It would be preferable to prevent randomized controlled trials (RCTs) with scientific misconduct from ever appearing in the peer-reviewed scientific literature, rather than to have to retract them later.

Objective:

To evaluate the policies of ob-gyn and top medical journals in their author guidelines and electronic submission systems regarding prospective RCT registration, ethics committee approval, research protocols, CONSORT guidelines, and data sharing, and to detect the most common quality criteria requested for RCTs in these journals.

Study design:

Author guidelines were identified via on-line Google searches from the websites of selected peer-reviewed medical journals. Journals in ob-gyn were selected from the list of journals with impact factors (IF) based on Journal Citation Report (JCR) released by Clarivate Analytics on June 29, 2020, focusing on those publishing original clinical research in obstetrics, in particular RCTs. In addition, four of the top IF peer-reviewed general medical journals publishing RCTs were included. The requirements for selected quality criteria for RCTs analyzed in the author guidelines for each journal were details of five general issues: prospective RCT registration (four subcategories); ethics committee approval (four subcategories); research protocol (three subcategories); CONSORT guidelines (three subcategories); and data sharing (three subcategories). To evaluate the requirements within the electronic submission system, a mock submission of an RCT was also done for each journal, and the same criteria were assessed on the online software for submission. The primary outcome was the overall percentage for each of the quality criteria that were listed as required within the author guidelines or required in the submission system amongst all journals. Planned subgroup analyses were top general medicine versus ob-gyn journals and top four ob-gyn versus other ob-gyn journals.

Results:

The majority of the studied peer-reviewed journals listed in their author guidelines seven specific criteria for submission of RCTs: prospective registration and registration number; statement of ethical approval with name of approving committee and statement of informed consent; statement of adherence to CONSORT guidelines; and data sharing statement. For the majority of journals, the submission software did not require these or any other criteria for submission. There were minimal differences in criteria listed for top medical journals versus other ob-gyn journals, and among top versus other ob-gyn journals.

Conclusions:

Prospective registration and registration number; statement of ethical approval with name of approving committee and statement of informed consent; statement of adherence to CONSORT guidelines; and data sharing statement are the RCT quality criteria requested by leading medical and ob-gyn journals. These ob-gyn journals agree to make, as much as possible, these criteria uniform and mandatory in author guidelines, and also through improved submission software.

Condensation:

Registration, ethical approval, CONSORT, and a data-sharing statement are RCT quality criteria requested by leading medical and ob-gyn journals.

Introduction

Well-conducted randomized controlled trials (RCTs) are considered to be the pinnacle of scientific evidence for the effectiveness and safety of interventions in medicine.¹ On the other hand, biased RCTs can lead to use of unnecessary, or even harmful, interventions.² RCTs and meta-analyses of RCTs are often the basis for changes in national and international guidelines.³ Unfortunately, studies published in peer-reviewed medical journals, including within the field of ob-gyn, have been found to be plagiarized or at fault of other scientific misconduct.⁴ Recently, 129 retracted manuscripts in obstetrics were identified in RetractionWatch⁵ and/or PubMed.⁶ Others have questioned the validity of some published RCTs in obstetrics using Monte-Carlo analysis, a modeling technique that simulates a large quantity of random trials from a given dataset and can determine the probability that the reported data in an RCT resulted from groups that were appropriately randomized.^7,8 This problem is not just restricted to ob-gyn journals, but is widespread throughout the medical literature, and may not be simple or straightforward to detect.^9,10 Although the Monte-Carlo analysis might be considered as an appropriate screening tool to suspect nonrandom sampling in RCTs¹¹, whether this method is sufficiently robust, accurate, and legitimate to prove data falsification and retract papers based on such analysis alone remains debatable.¹²

It would be preferable to prevent RCTs with scientific misconduct from ever appearing in the peer-reviewed scientific literature, rather than to have to retract them later. Suggested quality criteria have been suggested for editors to evaluate to ensure that the RCT actually occurred and that the data can be trusted as valid. The International Committee of Medical Journal Editors (ICMJE) now requires all of its affiliated journals to mandate registration of RCTs in a publicly available registry before first patient enrollment. In addition, journals that comply with ICMJE guidance must require submission of a data sharing plan with all RCT manuscripts.¹³ Other groups have also designed tools to increase the quality and transparency of RCT reporting. The Consolidated Standards of Reporting Trials (CONSORT) guidelines consist of a 25-item checklist of informtion that should be included in the RCT manuscript and a flow diagram template for authors to illustrate the progress of participants throughout the trial (available at http://www.consort-statement.org).¹⁴ The Committee on Publication Ethics (COPE) recommends that editors encourage adherence to the CONSORT guidelines and include evidence of appropriate ethical approval for the study.¹⁵ A novel risk assessment tool incorporating some of these criteria has been proposed to decrease the occurrences of fabricated studies being published.¹⁶ In this study, we chose to focus on 5 general issues (trial registration, ethics approval, availability of trial protocols, adherence to CONSORT guidelines, and data sharing) given their endorsement by the aforementioned research publishing committees and their general ease of identification within a manuscript submission.

The objective of this study was to identify and compare the policies of ob-gyn and top medical journals in their author guidelines and electronic submission systems regarding prospective RCT registration, international review board (IRB)/ethics committee approval, research protocol, CONSORT guidelines, and data sharing, and to detect the most common quality criteria requested for RCTs in these journals.

Materials and Methods

Author guidelines were identified via on-line Google searches in a regular window using the following key words: (journal name) + “author” + “guidelines.” From this search, the official website of the targeted peer-reviewed medical journal was accessed, and the guidelines reviewed on the website itself or downloaded as a PDF file, if available, from the websites of selected peer-reviewed medical journals. Journals in ob-gyn were selected from the list of 82 ob-gyn journals with impact factors (IFs) based on the Journal Citation Report released by Clarivate Analytics on June 29, 2020,¹⁷ focusing on those publishing original clinical research in obstetrics, in particular, RCTs. A new obstetrical journal that does not yet have an IF but accepts submission of obstetrical RCTs was also included.¹⁸ In addition, 4 of the top IF peer-reviewed general medical journals that publish RCTs (The New England Journal of Medicine, Lancet, Journal of the American Medical Association, and British Medical Journal) were included. Author guidelines for all journals were accessed between November 11, 2020, and November 18, 2020 (K.A.). Data for this project were primarily collected by K.A., a fourth-year medical student independent from any journal, under the direct supervision of V.B.; all authors had a chance to review data collection and data tables before submission.

Requirements for selected quality criteria for RCTs were analyzed in the author guidelines (sometimes titled ‘Guidelines to authors’, ‘Instruction to authors’, or with other nomenclature) for each journal, including details of 5 general issues: prospective RCT registration (4 subcategories); IRB approval (4 subcategories); protocol (3 subcategories); CONSORT guidelines (3 subcategories); and data sharing (3 subcategories). The subcategories for these quality criteria were defined as presented in Supplementary Table 1. Some requirements may not be explicitly listed in the author guidelines but are mandatory items that must be included during the submission process. Various online submission platforms are used by journals to ensure that all necessary information is reported by the authors before processing the submission. The platforms for online submission used by the included journals in this study were: ScholarOne Manuscripts (10 journals), Editorial Manager (7 journals), EJPress (2 journals), Springer Nature (1 journal), and Manuscript Manager (1 journal). To evaluate the requirements for the same quality criteria within these electronic submission systems, a mock submission of an RCT was also done for each journal. During these mock submissions, blank documents were uploaded to the submission platform for all the required items. Mandatory fields during the submission process were evaluated with our selected quality criteria, as described in Supplementary Table 1. These mock submissions were performed for all journals between November 11, 2020, and November 25, 2020 (K.A.). Therefore, data for all subcategories were extracted from both the author guidelines and the submission software. Further evaluation of these criteria or any other quality checks done by journals’ editorial staff or editors before processing the submitted manuscript further were not included.

The primary outcome was the overall percentage of each of the quality criteria that was required in either the author guidelines or submission system amongst all journals. Planned subgroup analyses were top general medicine versus ob-gyn journals and top 4 ob-gyn journals (by IF) versus other ob-gyn journals.

Results

Notably, 17 ob-gyn journals and 4 of the top general medicine journals (by IF) were studied for the 5 RCT quality criteria, making a total of 21 journals included in the analysis. Regarding trial registration, prospective registration was listed as a requirement in 11 of 21 (52.4%) of journals’ author guidelines and required in 2 of 21 (9.5%) online submission sites (Table 1). Registration number was listed as a requirement in 17 of 21 (81%) of journals’ author guidelines and required in 5 of 21 (23.8%) submission sites. Registry name was listed as a requirement in 9 of 21 (42.9%) of journals’ author guidelines and required in 3 of 21 (14.3%) submission sites. The Uniform Resource Locator (URL) of registration was listed as a requirement in 6 of 21 (28.6%) of journals’ author guidelines and required in 4 of 21 (19.0%) submission sites.

Table 1:

Requirements for Trial Registration

Title	Prospective Registration		Registration Number		Registry Name		URL of Registration
	Author Guidelines	Submission Site	Author Guidelines	Submission Site	Author Guidelines	Submission Site	Author Guidelines	Submission Site
NEJM	Yes	No	Yes	Yes	Yes	Yes	No	No
Lancet	No	No	Yes	No	Yes	No	No	No
JAMA	Yes*	No	Yes	Yes	Yes	Yes	Yes	Yes
BMJ	Yes*	No	Yes	No**	Yes	No**	No	No**
AJOG	Yes	Yes	Yes	Yes	No	No	Yes	Yes
UOG	No	No	No	No	No	No	No	No
OG	Yes	No	Yes	No	Yes	No	Yes	No
BJOG	Yes†	No	Yes	No**	No	No	Yes	No
AOGS	Yes†	No	Yes	No	Yes	No	Yes	No
Prenatal Diagnosis	No‡	No	Yes	No	Yes	No	No	No
Archives of Gynecology & Obstetrics	No‡	No	Yes	No	No	No	No	No
BMC Pregnancy	No‡	No	Yes	No	No	No	No	No
IJGO	Yes	No	No	No	No	No	No	No
Fetal Dx Rx	No	No	Yes	No	No	No	No	No
Journal of Perinatology	No	No	Yes	Yes	Yes	Yes	No	Yes
EJOG	No	No	No	No	No	No	No	No
JMFNM	Yes	No	Yes	No	No	No	No	No
ANZJOG	Yes	No	Yes	No**	No	No**	No	No
J Perinatal Med	No	No	No	No	No	No	No	No
Am J Perinatology	No	No	Yes	No	Yes	No	No	No
AJOG MFM	Yes	Yes	Yes	Yes	No	No	Yes	Yes
Totals	11 (52.4%)	2 (9.5%)	17 (81.0%)	5 (23.8%)	9 (42.9%)	3 (14.3%)	6 (28.6%)	4 (19.0%)
Total (Either/or)	11 (52.4%)		17 (81.0%)		9 (42.9%)		7 (33.3%)

^*Prospective registration required for studies commencing after July 2005

^**Field is not required to proceed, but asks for confirmation that it is present in the manuscript

^†Prospective registration required for studies commencing after July 2008

^‡Allowance for retrospective registration if statement of retroactive registration is present in abstract

Abbreviations: NEJM, New England Journal of Medicine; JAMA, Journal of the American Medical Association; BMJ, British Medical Journal; AJOG, American Journal of Obstetrics and Gynecology; UOG, Ultrasound in Obstetrics and Gynecology; OG, Obstetrics and Gynecology; BJOG, British Journal of Obstetrics and Gynecology; AOGS, Acta Obstetricia et Gynecologica Scandinavica; IJGO, International Journal of Gynecology and Obstetrics; Fetal Dx Rx, Fetal Diagnosis and Therapy; EJOG, European Journal of Obstetrics and Gynecology; JMFNM, Journal of Maternal Fetal Neonatal Medicine; ANZJOG, Australia New Zealand Journal of Obstetrics and Gynecology; AJOG MFM, American Journal of Obstetrics and Gynecology Maternal-Fetal Medicine; J, Journal.

Regarding IRB approval, statement of ethical approval was listed as a requirement in 21 of 21 (100%) of journals’ author guidelines and required in 10 of 21 (47.6%) submission sites (Table 2). Statement of informed consent was listed as a requirement in 17 of 21 (81.0%) of journals’ author guidelines and required in 3 of 21 (14.3%) submission sites. Name of the approving committee was listed as a requirement in 13 of 21 (61.9%) of journals’ author guidelines and required in 0 of 21 (0%) submission sites. Reference ID of approval was listed as a requirement in 8 of 21 (38.1%) of journals’ author guidelines and required in 2 of 21 (9.5%) submission sites.

Table 2:

Requirements for Ethical Approval

Title	Statement of Ethical Approval		Statement of Informed Consent		Name of Approving Committee		Reference ID of Approval
	Author Guidelines	Submission Site	Author Guidelines	Submission Site	Author Guidelines	Submission Site	Author Guidelines	Submission Site
NEJM	Yes	No	Yes	No	No	No	No	No
Lancet	Yes	No*	Yes	No	Yes	No	No	No
JAMA	Yes	No	Yes	No	No	No	No	No
BMJ	Yes	No*	Yes	No*	Yes	No*	Yes	No
AJOG	Yes	Yes	Yes	Yes	No	No	Yes	Yes
UOG	Yes	Yes	No	No	No	No	No	No
OG	Yes	Yes	No	No	Yes	No	No	No
BJOG	Yes	No	No	No	Yes	No	Yes	No
AOGS	Yes	Yes	Yes	No	Yes	No	Yes	No
Prenatal Diagnosis	Yes	Yes	Yes	Yes	Yes	No	No	No
Archives of Gynecology Obstetrics	Yes	No	Yes	No	Yes	No	No	No
BMC Pregnancy	Yes	No	Yes	No	Yes	No	Yes	No
IJGO	Yes	No	Yes	No	No	No	No	No
Fetal Dx Rx	Yes	No*	Yes	No*	Yes	No	Yes	No
J Perinatology	Yes	No	Yes	No	Yes	No	Yes	No
EJOG	Yes	No	Yes	No	No	No	No	No
JMFNM	Yes	Yes	Yes	No	No	No	No	No
ANZJOG	Yes	Yes	No	No	Yes	No*	Yes	No*
J Perinatal Med	Yes	Yes	Yes	No	Yes	No	No	No
Am J Perinatology	Yes	Yes	Yes	No	Yes	No	No	No
AJOG MFM	Yes	Yes	Yes	Yes	No	No	No	Yes
Totals	21 (100%)	10 (47.6%)	17 (81.0%)	3 (14.3%)	13 (61.9%)	0 (0%)	8 (38.1%)	2 (9.5%)
Total (Either/Or)	21 (100%)		17 (81.0%)		13 (61.9%)		9 (42.9%)

^*Not a required field, but asks for confirmation that this is present in the manuscript. Abbreviations as per Table 1.

Regarding protocol submission, submission of original protocol was listed as a requirement in 5 of 21 (23.8%) of journals’ author guidelines and required in 1 of 21 (4.8%) submission sites (Table 3). Submission of statistical analysis plan was listed as a requirement in 3 of 21 (14.3%) of journals’ author guidelines and required in 0 of 21 (0%) submission sites. A description of amendments to the original protocol was listed as a requirement in 3 of 21 (14.3%) of journals’ author guidelines and required in 0 of 21 (0%) submission sites.

Table 3:

Requirements for Protocol Submission

Title	Submission of Original Protocol		Submission of Statistical Analysis Plan		Amendments to Original Protocol
	Author Guidelines	Submission Site	Author Guidelines	Submission Site	Author Guidelines	Submission Site
NEJM	Yes	No*	Yes	No*	Yes	No
Lancet	Yes	Yes	No	No	No	No
JAMA	Yes	No**	Yes	No**	Yes	No
BMJ	Yes	No	Yes	No*	Yes	No
AJOG	No	No	No	No	No	No
UOG	No	No	No	No	No	No
OG	No	No	No	No	No	No
BJOG	Yes	No†	No	No	No	No†
AOGS	No	No	No	No	No	No
Prenatal Diagnosis	No	No	No	No	No	No
Archives of Gynecology and Obstetrics	No	No	No	No	No	No
BMC Pregnancy	No	No	No	No	No	No
IJGO	No	No	No	No	No	No
Fetal Dx Rx	No	No	No	No	No	No
J Perinatology	No	No	No	No	No	No
EJOG	No	No	No	No	No	No
JMFNM	No	No	No	No	No	No
ANZJOG	No	No	No	No	No	No
J Perinatal Med	No	No	No	No	No	No
Am J Perinatology	No	No	No	No	No	No
AJOG MFM	No	No	No	No	No	No
Totals	5 (23.8%)	1 (4.8%)	3 (14.3%)	0 (0%)	3 (14.3%)	0 (0%)
Total (Either/Or)	5 (23.8%)		3 (14.3%)		3 (14.3%)

^*Listed as an option for document type to upload, but not a requirement

^**Requirement of submission is mentioned on the portal, but can proceed without uploading

^†Required attestation that protocol and amendments were submitted online

Abbreviations as per Table 1.

Regarding CONSORT reporting guidelines, statement of adherence to CONSORT guidelines was listed as a requirement in 17 of 21 (81.0%) of journals’ author guidelines and required in 5 of 21 (23.8%) submission sites (Table 4). Submission of flow diagram was listed as a requirement in 8 of 21 (38.1%) of journals’ author guidelines and required in 0 of 21 (0%) submission sites. Submission of checklist was listed as a requirement in 6 of 21 (28.6%) of journals’ author guidelines and required in 0 of 21 (0%) submission sites.

Table 4:

Requirements for CONSORT Reporting Guidelines

Title	Statement of Adherence to Consort Guidelines		Submission of Flow Diagram		Submission of Checklist
	Author Guidelines	Submission Site	Author Guidelines	Submission Site	Author Guidelines	Submission Site
NEJM	Yes	No	Yes	No	No*	No
Lancet	Yes	No	No	No	No	No
JAMA	Yes	Yes	Yes	No**	Yes	No**
BMJ	Yes	Yes	Yes	No	Yes	No†
AJOG	Yes	No	Yes	No	No	No‡
UOG	Yes	Yes	No	No	No	No†
OG	Yes	No	No	No	Yes	No‡
BJOG	Yes	Yes	Yes	No†	Yes	No†
AOGS	No	No	No	No	No	No
Prenatal Diagnosis	Yes	No	No	No	No	No
Archives of Gynecology and Obstetrics	Yes	No	No	No	No	No
BMC Pregnancy	Yes	No	No	No	No	No
IJGO	Yes	No	Yes	No	No	No
Fetal Dx Rx	Yes	No	No	No	No	No
J Perinatology	Yes	No	No	No	Yes	No
EJOG	Yes	Yes	No	No	No	No†
JMFNM	No	No	No	No	No	No
ANZJOG	Yes	No	Yes	No	Yes	No
J Perinatal Med	No	No	No	No	No	No
Am J Perinatology	No	No	No	No	No	No
AJOG MFM	Yes	No	Yes	No	No	No
Totals	17 (81.0%)	5 (23.8%)	8 (38.1%)	0 (0%)	6 (28.6%)	0 (0%)
Total (Either/Or)	17 (81.0%)		8 (38.1%)		6 (28.6%)

^*Submission of this item noted as “encouraged”

^**Requirement of submission is mentioned, but can proceed without uploading this item

^†Required attestation that the document was uploaded, but can proceed without uploading this item

^‡Listed as an option for document types to upload, but not a requirement

Abbreviations as per Table 1.

Regarding data sharing, data sharing statement was listed as a requirement in 13 of 21 (61.9%) of journals’ author guidelines and required in 8 of 21 (38.1%) submission sites (Table 5). Data available for sharing on request was listed as a requirement in 3 of 21 (14.3%) of journals’ author guidelines and required in 1 of 21 (4.8%) submission sites. Mandated data sharing was listed as a requirement in 0 of 21 (0%) of journals’ author guidelines and required in 0 of 21 (0%) submission sites.

Table 5:

Requirements for Data Sharing

Title	Data Sharing Statement Required		Data Available for Sharing on Request		Mandated Data Sharing
	Author Guidelines	Submission Site	Author Guidelines	Submission Site	Author Guidelines	Submission Site
NEJM	Yes	Yes	No	No	No	No
Lancet	Yes	No	No	No	No	No
JAMA	Yes	Yes	No	No	No	No
BMJ	Yes	Yes	Yes	Yes	No	No
AJOG	No*	No	Yes	No	No	No
UOG	Yes	Yes	No	No	No	No
OG	Yes	No	No	No	No	No
BJOG	Yes	Yes	No	No	No	No
AOGS	Yes	No	No	No	No	No
Prenatal Diagnosis	Yes	Yes	No	No	No	No
Archives of Gynecology and Obstetrics	No	Yes	No	No	No	No
BMC Pregnancy	Yes	No	No	No	No	No
IJGO	Yes	No	No	No	No	No
Fetal Dx Rx	No	No	No	No	No	No
J Perinatology	No*	No	Yes	No	No	No
EJOG	Yes	No*	No	No	No	No
JMFNM	No*	Yes	No	No	No	No
ANZJOG	Yes	No	No	No	No	No
J Perinatal Med	No	No	No	No	No	No
Am J Perinatology	No	No	No	No	No	No
AJOG MFM	No*	No	No	No	No	No
Totals	13 (61.9%)	8 (38.1%)	3 (14.3%)	1 (4.8%)	0 (0%)	0 (0%)
Total (Either/Or)	15 (71.4%)		3 (14.3%)		0 (0%)

^*Data sharing statement is encouraged but not listed as required

Abbreviations as per Table 1.

In the subgroup analyses, the top 4 medical journals required registry name and the 3 criteria related to research protocols more often than the ob-gyn journals (Supplementary Table 2). The top 4 ob-gyn journals required the registration URL more often than the other ob-gyn journals (Supplementary Table 3).

Discussion

Main results

Most studied peer-reviewed journals listed in their author guidelines 7 specific criteria for submission of RCTs: prospective registration and registration number; statement of ethical approval with name of approving committee and statement of informed consent; statement of adherence to CONSORT guidelines; and data sharing statement. For most journals, the submission software did not require these or any other criteria for submission. There were minimal differences in criteria listed for top medical journals compared with other ob-gyn journals or among top versus other ob-gyn journals.

Strengths and limitations

To our knowledge, such a detailed review of author guidelines and submission software has not been performed before. By design, the focus was on quality criteria for RCTs. A limitation is that there are other possible quality criteria for RCTs that we did not include, such as data safety monitoring committee, independent data analysis, sponsor (e.g. industry vs non-industry; etc.), number of authors, and number of institutions or centers. We chose to focus on the included criteria because they are recommended by international organizations for research reporting (ICMJE and COPE) and are straightforward to evaluate within a manuscript submission. Another limitation is the small sample size, in particular for the subgroup analyses. We limited our analysis to journals that publish obstetrical RCTs in English language. Furthermore, we are aware of the fact that editorial staff or editors of several of these journals perform a quality check of the submissions to make sure that the author guidelines are followed, as the submission software does not control all the requirements. Additional steps, including similarity checks with previously published studies using plagiarism detection software before sending for peer-review, are also routinely practiced by many journals. However, we were not able to include such information for each journal in our analyses.

Further research

Further research is necessary to determine how to make the definition of these and other quality criteria more precise. Additionally, submission software should be developed to make some of these criteria required on submission. For example, for prospective registration, a software that ‘reads’ the date of registration and ensures that it is antecedent to the date of first patient enrollment is needed. The software should also automatically check the link to the RCT registration site, and ensure that it is a valid URL and an accepted registration site, and that the correct RCT is registered.

Further research is also needed to determine which of these criteria is best at distinguishing valid versus untrustworthy RCTs, as there is limited literature in this area. If we compare RCTs with proven scientific misconduct to ‘valid’ RCTs, it is important to analyze which of these (or other) criteria are the most accurate at making this distinction.

Implications

As editors of peer-reviewed obstetrical journals, based on this review, we agreed to try to make our author guidelines for submission of RCTs more uniform across our journals. Given that most journals listed these as necessary criteria, all have agreed to require the following: prospective registration and registration number; statement of ethical approval with name of approving committee and statement of informed consent; statement of adherence to CONSORT guidelines; and data sharing statement. Moreover, there will be efforts so that these criteria will be not only listed in each journal’s author guidelines, but will also be required on the journals’ submission website so that submission is not allowed without meeting each of these 7 criteria.

Conclusions

Of note, 7 of the 17 quality criteria for RCTs studied were listed as requirements in most author guidelines for the journals analyzed and included: prospective registration and registration number; statement of ethical approval with name of approving committee and statement of informed consent; statement of adherence to CONSORT guidelines; and data sharing statement. In hopes of continuing to ensure that only valid RCTs are published, ob-gyn journals publishing obstetrical RCTs agree to make these criteria uniform and mandatory. Efforts by editors are underway to improve journals’ guides to authors and submission software to implement these submission requirements. The ultimate aim is to continue to inform medical journals of the best ways to identify upon submission those RCTs that have scientific misconduct and to prevent these RCTs from ever being published. In addition, adherence to the 7 criteria has the potential to increase transparency, restore confidence in the results of trials, and through data sharing, expedite individual data meta-analyses.

AJOG MFM at a Glance:

A. Why was this study conducted?

Most retractions of ob-gyn manuscripts are due to scientific misconduct. It would be preferable to prevent randomized controlled trials (RCTs) with scientific misconduct from ever appearing in the peer-reviewed scientific literature, rather than to have to retract them later.

B. What are the key findings?

Prospective RCT registration and registration number; statement of ethical approval with name of approving committee and statement of informed consent; statement of adherence to CONSORT guidelines; and data sharing statement are the RCT quality criteria requested by leading medical and ob-gyn journals.

C. What does this study add to what is already known?

There was no prior evaluation of quality criteria for obstetrical RCTs requested in author guidelines or submission software. Selected ob-gyn journals agree to make, as much as possible, these criteria uniform and mandatory in author guidelines and through improved submission software.